FDA Registration
Active
🇺🇸 United States
BENCHMARK ELECTRONICS, INC.
Reg #: 2133641
·
FEI: 3000203466
·
Expires 2026
Products
48
Proprietary Names
0
Establishment Types
1
Classifications
48
Registration Details
- Registration Name
- BENCHMARK ELECTRONICS, INC.
- Registration Number
- 2133641
- FEI Number
- 3000203466
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4065 THEURER BLVD.
- City
- WINONA
- State
- MN
- ZIP
- 55987
- Country
- US
Owner / Operator
- Firm Name
- BENCHMARK ELECTRONICS, INC.
- Operator Number
- 1641405
- Address
- 56 S Rockford Dr., --
- City
- Tempe
- State
- AZ
- Postal Code
- 85288
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2015-07-27 |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2015-07-27 |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | Class 3 | Unknown | No | 2016-12-21 |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | Class 3 | Unknown | No | 2016-12-21 |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | Class 3 | Unknown | No | 2016-12-21 |
| Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | OHV | Class 2 | General, Plastic Surgery | No | 2025-07-14 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-07-14 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2024-09-25 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2024-09-25 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-07-14 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2025-07-14 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2025-07-14 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2025-07-14 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2025-12-16 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-12-16 |
| Cannula, Catheter | DQR | Class 2 | Cardiovascular | No | 2024-09-25 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2024-09-25 |
| Adjunctive Predictive Cardiovascular Indicator | QAQ | Class 2 | Cardiovascular | No | 2024-09-25 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2024-09-25 |
| Device, Vein Location, Liquid Crystal | KZA | Class 1 | General Hospital | No | 2010-12-28 |
| Sterilizer, Ethylene-Oxide Gas | FLF | Class 2 | General Hospital | No | 2015-02-17 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2021-06-05 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2021-11-02 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2021-11-02 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2025-07-14 |
| Cerebral Oximeter | QEM | Class 2 | Cardiovascular | No | 2025-07-14 |
| Medium-Term Adjunctive Predictive Cardiovascular Indicator | QNL | Class 2 | Cardiovascular | No | 2025-07-14 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-07-14 |
| Adjunctive Open Loop Fluid Therapy Recommender | QMS | Class 2 | Cardiovascular | No | 2025-07-14 |
| Catheter, Oximeter, Fiber-Optic | DQE | Class 2 | Cardiovascular | No | 2025-07-14 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2021-11-02 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2021-11-02 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2021-11-02 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2020-03-18 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2022-03-25 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2022-03-25 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2021-11-02 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2017-11-27 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2020-03-18 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2006-07-12 |
| Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | OJX | Class 3 | Unknown | No | 2006-07-12 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2006-07-12 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2024-09-25 |
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2015-12-09 |
| Leadless Pacemaker | PNJ | Class 3 | Cardiovascular | No | 2022-06-15 |
| Pulse-Generator, Single Chamber, Sensor Driven, Implantable | LWO | Class 3 | Unknown | No | 2021-11-02 |
| Dorsal Root Ganglion Stimulator For Pain Relief | PMP | Class 3 | Unknown | No | 2026-06-12 |
| Wearable Automated External Defibrillator | MVK | Class 3 | Unknown | No | 2021-11-02 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)